Spina Bifida Clinical Trial
— PRIUM2Official title:
In Utero Fetoscopic Repair Program for Sacral Myelomeningoceles and Mye-LDM
The purpose of the study is to evaluate the feasibility and the maternal, fetal and postnatal outcomes of sacral myelomeningocele (MMC) and Myelic Limited Dorsal Myeloschisis (MyeLDM) fetoscopic repair at Trousseau Hospital (Paris, France).
Status | Recruiting |
Enrollment | 10 |
Est. completion date | August 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Inclusion Criteria : - Pregnant women age 18 years and older who are able to consent - Singleton pregnancy before 26 weeks of gestation, - Sacral MMC (upper level S1 or below) or MyeLDM diagnosed on ultrasound and MRI, 4. Absence of associated malformation apart from the anomalies usually observed in cases of open dysraphisms (i.e. feet malpositions, associated cerebral signs) or chromosomal anomaly if verification of the karyotype was desired by the couple - Affiliated to health insurance, understanding and speaking French - Written consent of the patient for the surgery and representatives of the parental authority for the postnatal follow-up of the child - Patient who made the choice to continue the pregnancy Exclusion Criteria: - Abnormal angulation of the fetal spine, - risk factors for prematurity: cervical length less < 15mm, history of late miscarriage before 22 weeks, pre-existing rupture of the membranes at inclusion, - Placenta praevia, - BMI greater than 35 kg / m2, - Abnormality of the uterus: large fibroid, uterine malformation, history of uterine body surgery - Maternal infection at risk of maternal-fetal transmission: HIV, HBV, HCV, - Surgical or anesthetic contraindication. - Participation in another interventional research protocol, - Patients under legal protection (guardianship, curatorship). - Allergies to drugs used in the research |
Country | Name | City | State |
---|---|---|---|
France | Service médecine foetale-Hôpital Trousseau | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ability to perform fetoscopic sacral MMC/MyeLDM repair without severe perinatal morbidity and mortality | Successful complete closure of the defect using the fetoscopic technique AND birth after 32 weeks without severe perinatal morbidity and mortality including grade III-IV intra ventricular hemorrhage, severe, cerebral parenchyma hemorrhage, periventricular leukomalacia, grade III ulcero-necrotizing enterocolitis, severe bronchodysplasia) | From time of surgery to 8 weeks of life (up to 28 weeks) | |
Secondary | Adverse Maternal outcome | diagnosis of maternal gas embolism, hemorrhage, thromboembolic complication, death | during the surgery | |
Secondary | Maternal obstetric outcome as evidenced by preterm labor leading to delivery at less than 37 weeks of gestation | Preterm labor occuring at any time from surgery leading to delivery before 37 weeks of gestation | From time of surgery until 37 weeks of gestation | |
Secondary | Maternal obstetric outcome as evidenced by preterm premature rupture of membranes | Preterm premature rupture of membranes occuring at any time from surgery until 37 weeks of gestation | From time of surgery until 37 weeks of gestation | |
Secondary | Maternal obstetric outcome as evidenced by chorioamnionitis | chorioamnionitis occuring at any time from surgery until 37 weeks of gestation | From time of surgery until 37 weeks of gestation | |
Secondary | Maternal obstetric outcome as evidenced by antenatal betamethasone treatment | indication for a betamethasone course occuring at any time from surgery until 34 weeks of gestation | From time of surgery until 34 weeks of gestation | |
Secondary | Other Maternal obstetric outcome as evidenced by hypertensive disorders, preeclampsia, gestational diabetes | hypertensive disorders, preeclampsia, gestational diabetes occuring any time from surgery until 37 weeks of gestation | From time of surgery until 37 weeks of gestation | |
Secondary | Prenatal evolution of brain abnormalities associated with open dysraphism, after fetoscopic repair | Difference in the growth of the cephalic perimeter measured on an axial ultrasound section | From time of surgery until birth | |
Secondary | Prenatal evolution of brain abnormalities associated with open dysraphism, after fetoscopic repair (1) | Difference in measurement of the ventricles on an axial ultrasound section | From time of surgery until birth | |
Secondary | Prenatal evolution of brain abnormalities associated with open dysraphism, after fetoscopic repair (2) | Difference in the measurement of the large retro-cerebellar cistern on an axial section of the posterior fossa | From time of surgery until birth | |
Secondary | Prenatal evolution of brain abnormalities associated with open dysraphism, after fetoscopic repair (3) | Proportion of patients with reversal of hindbrain herniation (i.e. lower limit of the vermis located above the foramen magnum on ultrasound and/or fetal MRI) | From time of surgery until birth | |
Secondary | Maternal obstetric outcome as evidenced by gestational age at delivery (1) | Gestational age of delivery regardless of indication | From time of surgery until delivery | |
Secondary | Maternal obstetric outcome as evidenced by gestational age at delivery (2) | Proportion of deliveries before 37 weeks of gestation | From time of surgery until delivery | |
Secondary | Maternal obstetric outcome as evidenced by the ability to deliver vaginally | Mode of delivery - either vaginal or cesarean section | From time of surgery until delivery | |
Secondary | Proportion of postpartum hemorrhages | Maternal obstetric outcome as evidenced by postpartum hemorrhage Proportion of postpartum hemorrhages defined by blood loss of more than 500mL for vaginal delivery, and 800mL for cesarean delivery | From time of surgery until delivery | |
Secondary | Need for maternal transfusion (number of blood cells transfused) | Maternal obstetric outcome as evidenced by postpartum hemorrhage Need for maternal transfusion (number of blood cells transfused) | From time of surgery until delivery | |
Secondary | Adverse neonatal outcome at birth (1) | Normal or abnormal birth parameters at birth depending on the term | at birth | |
Secondary | Adverse neonatal outcome at birth (2) | Proportion of fetal asphyxia (arterial pH at the umbilical cord <7.00) | at birth | |
Secondary | Adverse early childhood outcome as evidenced by need for a neurosurgical intervention | need for one of the following neurosurgery
Type 1: Superficial skin recovery surgery due to scar dehiscence Type 2: Need for surgical correction involving all aspects, without reopening the dura Type 3: Need for complete surgical correction with repair of the dural plane |
From the time of birth until 8 weeks of life | |
Secondary | Postnatal evolution of brain abnormalities associated with open dysraphism | Difference in the growth of the cephalic perimeter by measuring the cranial perimeter between birth and the age of 12 months | From the time of birth until 12 months of life | |
Secondary | Postnatal evolution of brain abnormalities associated with open dysraphism (1) | Difference in the measurement of the cerebral lateral ventricles measured during postnatal transfrontanellar ultrasound followed by cerebral MRI , | From the time of birth until 12 months of life | |
Secondary | Postnatal evolution of brain abnormalities associated with open dysraphism (2) | Proportion of patients with reversal of hindbrain herniation (i.e. lower limit of the vermis located above the foramen magnum on cerebral MRI) | From the time of birth until 12 months of life | |
Secondary | Postnatal evolution of brain abnormalities associated with open dysraphism (3) | Proportion of patients requiring a cerebrospinal fluid shunt within the first 12 months of life | From the time of birth until 12 months of life |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06065995 -
StoMakker Mobile Application
|
N/A | |
Not yet recruiting |
NCT06007885 -
Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention.
|
N/A | |
Completed |
NCT02854150 -
Improving Genetic Counseling for Patients With Spina Bifida Using Next Generation Sequencing
|
||
Completed |
NCT00655681 -
Prevention of Post Operative Bone Loss in Children
|
N/A | |
Completed |
NCT00378664 -
Lumbar to Sacral Ventral Nerve Re-Routing
|
Phase 2 | |
Active, not recruiting |
NCT00891891 -
Psychosocial Adjustment of Adolescents With Spina Bifida
|
||
Active, not recruiting |
NCT00031122 -
Study of Genetic Risk Factors for Spina Bifida and Anencephaly
|
N/A | |
Completed |
NCT03573726 -
Use of a Diurnal Indwelling Urethral Catheter to Improve Quality of Life
|
N/A | |
Completed |
NCT03851107 -
The Effectiveness of Participation-focused Interventions on Body Functions of Youth With Physical Disabilities
|
N/A | |
Not yet recruiting |
NCT03698721 -
Urothelium Tissue Engineering Using Biopsies From Transurethral Resection of Prostate
|
||
Recruiting |
NCT02938130 -
The Impact of Community-based Wellness Programs on The Triple Aim
|
N/A | |
Recruiting |
NCT02592291 -
Mobile Health Self-Management and Support System for Chronic and Complex Health Conditions
|
N/A | |
Not yet recruiting |
NCT05784285 -
Downstream Effects of Personalized 'Top-down' Participation-based Interventions Among Youth With Physical Disabilities
|
N/A | |
Completed |
NCT00720161 -
Metformin in Children With Motor Deficit
|
N/A | |
Completed |
NCT05861024 -
Urinary Calculi After Bladder Augmentation in Children
|
||
Completed |
NCT05858840 -
Urinary Artificial Sphincter in Children
|
||
Recruiting |
NCT03856034 -
Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele
|
N/A | |
Recruiting |
NCT04362592 -
In-Utero Endoscopic Correction of Spina Bifida
|
N/A | |
Enrolling by invitation |
NCT04186130 -
Fecal Microbium Change in Pediatric Patients With Spina Bifida: Prospective Case-control Study
|
||
Active, not recruiting |
NCT05117827 -
Pediatric Powered Wheelchair Standing Devices: An Exploratory Study
|
N/A |